Public Workshop Set on Drug Shortages

The Food and Drug Administration will host it from 8:30 a.m. to 4:30 p.m. Sept. 26 in Silver Spring, Md.

The Food and Drug Administration will host a public workshop Sept. 26 to review the current approach used by the agency's Center for Drug Evaluation and Research to address drug shortages, asking health care providers and others how to prevent or mitigate them.

The workshop will be held at 10903 New Hampshire Ave., Bldg. 31, room 1503 B and C (Great Room), Silver Spring, MD 20993. Information about special accommodations due to a disability, visitor parking, and transportation may be accessed at http://www.fda.gov/AdvisoryCommittees/default.htm under the heading "Resources for You."

"Given the increasing number of drug shortages and the attendant safety concerns for the public's health, it is important to discuss the causes of these shortages, as well as strategies to address them," FDA said in its meeting announcement, which said these topics will be discussed:

  • How CDER becomes aware of drug shortages
  • Reasons behind drug shortages
  • Determination of medically necessary products
  • Current good manufacturing practice and other compliance issues
  • Actions taken when a drug shortage occurs
  • Outcomes of mitigated drug shortages
  • The public health impact of drug shortages and how to prevent them

As soon as a transcript is available, it will be posted at www.regulations.gov (Docket No. FDA-2011-N-0002).

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Easy to Use Safety Incident App

    Record incidents on the go with IndustrySafe’s mobile app. Collect data for multiple types of incidents including including near misses, vehicle and environmental incidents, and employee and non-employee injuries; at job sites and remote locations—with or without web access.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. IndustrySafe is here to help. We put together a resource that’s easy to digest so you can get answers to your training questions and ensure you're complying with OSHA's standards.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus